Taiwan to Implement Cosmetic Online Recording System

Takehome:

To support Taiwan's newly revised "Statute for Control of Cosmetic Hygiene", a new online record system has been developed. The TFDA has stated that recording information before marketing will be mandatory when the new "Statute" is officially published.

The "Statute" draft stipulates that all cosmetics (general and medicated cosmetics) should file a record on the system before entering Taiwan's markets and unrecorded cosmetic products will be prohibited from sale. Currently, the system is ready for enterprise to record their products, and the operation is free. When the "Statute" draft is approved and officially published, the online record system will become mandatory and fees for record filing will be charged. We encourage stakeholders to record product information before the "Statute" is promulgated.

The system links with the national industry and commercial database of Ministry of Economic Affair. Enterprise with an industry and commercial certificate can login using the website: https://cos.fda.gov.tw/TCAL/index_ca.jsp. Enterprise without the industry and commercial certificate should apply for an account from TFDA and login on the website: https://cos.fda.gov.tw/TCAL/. After logging in, enterprises should fill out product information, responsible person, manufacturer, product package information and record statement.

Once the online record is complete, no certificate will be issued. The record system is an approach to simplify pre-market procedures and shift to post-market surveillance for cosmetic products. After filing the record, TFDA may ask for documentary evidence from enterprises or may conduct onsite inspection of manufacturing/processing plants and retail outlets to check if all information provided online is accurate.

This announcement is released partially, Chemlinked.com post it for your arrangement in advance. When the record system is formally implemented, TFDA will disclose the news through all cosmetic associations.